DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-17 in the reply filed on 9/8/2026 is acknowledged. The traversal is on the ground(s) that amended claim 18 recites substantially the same operative system architecture recited by amended claim 1. Claim 1 requires visual display devices, registering devices for registering neural activities, stimulation devices, and a processor having software and a database configured to record, recognize, extract, and interpret neural-activity signals and transmit commands to the visual display and/or stimulation devices using the claimed feedforward control. Method claim 18 correspondingly requires a visual display device, a neural-activity registering device, a processor having software and a database, recording/recognizing/extracting/interpreting the registered neural signals, transmitting commands to the visual display and/or stimulation devices, implementing the same feedforward control, and electrically stimulating the patient's neural system using a stimulation device.
Upon further review of the amended claims, the arguments are persuasive and therefore the restriction requirement has been withdrawn.
Claims 1-41 are being examined.
Claim Objections
Claim 30 is objected to because of the following informalities: Claim 30 must end in a period. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). (Please see MPEP section608.01(m)). Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are:” a plurality of registering devices” and “a plurality of stimulation devices”, “ a visual display device “ in claim 1. “Impacting devices” as claimed in claim 2.
According to the specification, the device for registering brain activity is one of an electroencephalograph (EEG), a near-infrared spectroscopy (NIRS), a magnetoencephalographic (MEG), a magnetic resonance imaging (MRI) or similar devices that read and register magnetic fields arising from the electrical activity of the brain. Stimulation devices are interpreted as a transcutaneous electrical stimulator of spinal cord and muscles and a vibrational soft plate as electrical and tactile stimulation devices. An impacting device is interpreted as a robotic device moving a trained limb. Visual display device is interpreted as a virtual reality headset.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites the limitation "the excitability threshold of the sensorimotor system" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the start of the rehabilitation” in lines 1-2 "the excitability threshold of the sensorimotor system" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Further claim 27 recites “in order to excitate the later before exercising”. It is unclear as to what this means
Claim 28 recites the limitation " the stimulation amplitude is set above the excitation threshold of the sensorimotor system” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 9, 15-22, 24, 25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of Just al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED).
Regarding claim 1, Averkiev a neurorehabilitation system (e.g. 23 Fig.1,3 [0094]: the neurorehabilitation system 23) comprising:
a plurality of visual display devices (e.g.1 Figs.1-3 ,[0094]: visual display device 1, which, usually, is a virtual reality device, which can be represented in the form of virtual reality headset (FIG. 2) as well as a virtual reality helmet, [0156]: In addition, all of the above options for implementing the method of neurorehabilitation can be combined: all together (FIG. 10)), wherein at least one device is configured to present a task execution progress (e.g. [0094]):
a plurality of registering devices (e.g. 2 Fig.1, 2,3,[0095]: EEG headset, near-infrared spectroscopy (NIRS) device can also be used to measure brain activity through hemodynamic responses associated with neuroactivity; also, a magnetic resonance imaging (MRI) device can be used that records nuclear magnetic resonance signals, as well as devices that read and register magnetic fields arising from the electrical activity of the brain. configured to register neural activities ... combination of these technologies can be implemented in a single compact device);
a plurality of stimulation devices for electrical stimulation (e.g. 5 Figs.1,4 [0099], [0118], [0126], [0127]; the combination of electrode 5 and 6 that help in stimulation of the knee joint [0153]); and
a processor (i.e. computer, e.g. 3 Fig.1,[0095]-[0098]) with a database and a software, wherein the software is configured to register (e.g. 11 Fig.5-10) and extract registered signals for an interpretation of the neural activity and forming the database (e.g. 11-13 Figs.5-10),
wherein the software is further configured to transmit commands formed on the basis of an interpretation of the registered signals of the neural activities to the at least one visual display device and/or to the at least one stimulation device (e.g. [0153]), and wherein the software is further configured to present the task execution progress of a trained object on the visual display device (e.g. [0097]: the computer 3 transmits the commands formed on the basis of the interpretation of the registered signals of brain and/or muscle activity to the robotic device 4 and/or to the visual display device 1 according to the transmit-receive principle, [0154], [0155]: display on the visual display device a degree of completion of a task).
Averkiev does not specifically teach implementing feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change.
In a similar field of endeavor, Just teaches a rehabilitation robot system (e.g. abstract) and further teach feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change (e.g. page 73 col.1 para 3, page 73 col. 2 para 2). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev to include the feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change as taught by Just in order to provide the predictable results of a model based feedforward control that is scalable, online adjustable and easily generalizable for any robotic system.
Regarding claim 2, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches a plurality of impacting devices configured to impact trained objects (i.e. robotic device for impacting a trained object e.g. 4 Figs 1-4,[0026], [0096],[0109] ) wherein the software is configured to transmit commands formed on the basis of the interpretation of the registered signals of the neural activities to the impacting devices (e.g. [0097]).
Averkiev does not specifically teach implementing feedforward control based on the anticipated change to modify impact to counteract the anticipated change.
In a similar field of endeavor, Just teaches a rehabilitation robot system (e.g. abstract) and further teach feedforward control based on the anticipated change to modify impact to counteract the anticipated change. (e.g. page 73 col.1 para 3, page 73 col. 2 para 2). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev to include the feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change as taught by Just in order to provide the predictable results of a model based feedforward control that is scalable, online adjustable and easily generalizable for any robotic system.
Regarding claim 3, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least two different registering devices are used simultaneously (e.g. [0095]: listed devices can be used in various combination, the most preferable variant of the combination of devices for recording brain activity 2 is the combined use of an electroencephalograph and a near infrared spectroscopy device.)
Regarding claim 4, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one of the registering devices is configured to register a brain neural activity (e.g. [0095]: electroencephalograph (FIG. 2) or a similar device can be used as a device for recording brain activity that records the electrical and bioelectric activity of the brain from the surface of the scalp. A near-infrared spectroscopy (NIRS) device can also be used to measure brain activity through hemodynamic responses associated with neuroactivity; also, a magnetic resonance imaging (MRI) device can be used that records nuclear magnetic resonance signals, as well as devices that read and register magnetic fields arising from the electrical activity of the brain).
Regarding claim 5, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches wherein at least one of the registering devices is configured to register a muscular neural activity (i.e. electromyograph e.g. 6 Figs.1,3,4, [0119],[0127]).
Regarding claim 9, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one of the stimulation devices is a functional electrical stimulation device which has at least one stimulation channel (e.g. [0099]: electrostimulator 5 implements electrical stimulation in the neurorehabilitation system, which consists of the simultaneous movement of the trained object by the robotic device 4 with a specific electrical effect through the skin on certain muscle and nerve fibers in order to enhance biofeedback and stimulate the muscles own activity and the formation of patterns of neuronal activity corresponding to the implementation of desired movements).
Regarding claim 15, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one impacting device can use the registered signals by at least one registering device for configuring impact parameters (e.g. [0148]: the commands are formed on the basis of the interpretation of the registered signals and transmitted to the robotic device to impact the trained object since the exoskeleton uses anatomical parameterization in order to impact the limb).
Regarding claim 16, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches the at least one impact parameter of at least one of the impacting devices can be configured based on the registered signals by at least one of the registering devices (e.g. [0148]: the commands are formed on the basis of the interpretation of the registered signals and transmitted to the robotic device to impact the trained object).
Regarding claim 17, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches wherein the plurality of visual display devices comprises a single visual display device and/or the plurality of registering devices comprises a single registering device and/or the plurality of stimulation devices comprises a single stimulation device (e.g. Figs 1-4, [0094], [0095], [0099]).
Regarding claim 18, Averkiev a method of neurorehabilitation (e.g. 23 Fig.1,3, 4,5 [0094], [0129]), the method comprising:
presenting via a visual display device a task to be performed by trained objects (e.g. 10 Fig.5, [0130]);
registering signals of neural activities by at least one registering device (e.g. 11 Fig.5, [0131]);
transmitting registered signals of neural activity to a processor with a software having or connected to a database (e.g. 12 Fig.5, [0132]);
recording, recognizing, extracting, and interpreting the registered signals necessary for interpretation of the neural activities by the processor (e.g. 13 Fig.5, [0133]);
learning by the software to extract the registered signals necessary for interpretation of neural activity and forming the database (e.g. 16 Fig.6 [0146],[0147]: neural network and classifiers) ;
interpreting the registered signals using the database (e.g. 13 Fig.5,6, [0133]);
transmitting commands formed on the basis of the interpretation of the registered signals of the neutral activities to the visual display device and/or the stimulation devices (e.g. 14 Fig. 5, [0134]) and
stimulating via an electrical stimulation the neural system of a patient by at least one stimulation device using at least one stimulation channel (e.g. 21 Fig. 8, [0099],[0153]);
transmitting signals to the visual display device (e.g. 16 Fig. 5, [0136]); and
presenting on the visual display device the task execution a task execution progress performance of the trained object (e.g. [0097]: the computer 3 transmits the commands formed on the basis of the interpretation of the registered signals of brain and/or muscle activity to the robotic device 4 and/or to the visual display device 1 according to the transmit-receive principle, [0154], [0155]: display on the visual display device a degree of completion of a task).
Averkiev does not specifically teach implementing feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change.
In a similar field of endeavor, Just teaches a rehabilitation robot system (e.g. abstract) and further teach feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change (e.g. page 73 col.1 para 3, page 73 col. 2 para 2). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev to include the feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change as taught by Just in order to provide the predictable results of a model based feedforward control that is scalable, online adjustable and easily generalizable for any robotic system.
Regarding claim 19, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches impacting at least one trained object by at least one impact device (e.g. 14 Fig. 5, [0134],[0135]). Averkiev does not specifically teach implementing feedforward control based on the anticipated change to modify impact to counteract the anticipated change.
In a similar field of endeavor, Just teaches a rehabilitation robot system (e.g. abstract) and further teach feedforward control based on the anticipated change to modify impact to counteract the anticipated change. (e.g. page 73 col.1 para 3, page 73 col. 2 para 2). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev to include the feedforward control based on an anticipated change to modify visualization and/or stimulation to counteract the anticipated change as taught by Just in order to provide the predictable results of a model based feedforward control that is scalable, online adjustable and easily generalizable for any robotic system.
Regarding claim 20, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at the step of extraction and recognition of the registered signals of the neural activities of at least one of the signals of neural activity is selected from the group consisting of: a cortical visual evoked potential, a cortical motor imagination, a neuromuscular activity (e.g. [0102]: acting on limb), evoked responses from the spinal cord and/or brain, electrically evoked compound action potentials, or mechanical and kinematical correlates of motor activity.
Regarding claim 21, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches the results of extraction and recognition of the registered signals of the neural activities are used to control at least one impact device (e.g. 4 Fig. 5, [0109]) or/and at least one stimulation device comprising at least one channel each.
Regarding claim 22, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches the registered signals of the neural activities are used to control the at least one impact device (e.g. 14 Fig. 5 ,[0134]) and/or at least one stimulation channel of at least one stimulation device based on a stage of a visual-motor transformation process determined using the registered signals of the neural activities (e.g. [0155]: It is possible to implement the neurorehabilitation method, in which the task, registration of signals and commands to perform the task are divided into several stages, while each stage of the task can be recorded by a different device, performed by different parts of the trained object, and each stage is displayed on the visual display device 1 independently).
Regarding claim 24, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches the registered signals of the neural activities are used to control stimulation channels of at least one stimulation device in a way mimicking the natural propagation of the neural signals during a voluntary muscular action based on the stage of the visual-motor transformation process determined using the extracted signals of neural activity (e.g. Fig. 8, [0099],[0153],[0155]).
Regarding claim 25, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches stimulation by at least one channel of at least one stimulation device is synchronized with an action of at least one impact device (e.g. [0099]) and /or with visual presentation on a visual display device of the task being performed.
Regarding claim 30, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches the patient is alternately given motor tasks to execute either by an affected limb driven by the impact device or by the corresponding intact limb driven by the own muscular effort (e.g. [0100]).
Claims 6-8, 10-14, 23, 31-34 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of JUST al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED) and further in view of Grahn et al (U.S. Patent Application Publication Number: US 2021/0052889 A1, hereinafter “Grahn”- APPLICANT CITED).
Regarding claim 6, Averkiev in view of Just teaches the claimed invention as discussed above except for at least two different stimulation devices being used simultaneously.
In a similar field of endeavor, Grahn teaches epidural stimulation (e.g. Abstract) wherein at least two different stimulation devices are being used simultaneously (e.g. [0005]: EES system can include two or more implantable pulse (waveform) generators (IPGs), the system includes a multi-electrode array and at least two independent IPGs configured to independently deliver multiple stimulation programs simultaneously). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Averkiev in view of Just to include two different stimulation devices to provide simultaneous stimulation as taught by Grahn in order to provide the predictable results of providing targeted stimulation to a person having incomplete or complete spinal cord injury.
Regarding claim 7, Averkiev in view of Just teaches the claimed invention as discussed above except for at least one of the devices for registering the neural activities comprises at least one invasive element.
Grahn teaches surgically implanting an epidural electrical system (EES) and monitoring the implanted electrodes to coordinate stimulation to affect motion and therefore they teach at least one device for registering the neural activities comprising at least one invasive element (e.g. [0058]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Averkiev in view of Just to include at least one of the devices for registering the neural activities to comprise at least one invasive element as taught by Grahn in order to provide the predictable results of activating motor function by providing targeted stimulation to a person having incomplete or complete spinal cord injury.
Regarding claim 8, Averkiev in view of Just teaches the claimed invention as discussed above except for at least one of the stimulation devices is a spinal cord electrical stimulation device which has at least one stimulation channel.
Grahn teaches stimulation devices that provide a spinal cord electrical stimulation which have at least one stimulation channel (e.g. Abstract, [0059]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with the epidural stimulation devices as taught by Grahn in order to provide the predictable results of activating motor function by providing targeted stimulation to a person having incomplete or complete spinal cord injury.
Regarding claim 10, Averkiev in view of Just teaches the claimed invention as discussed above except for at least one of the stimulation devices is a tactile (haptic) stimulation device which has at least one stimulation channel.
Grahn teaches at least one stimulation device that provides spinal cord electrical stimulation and providing a tactile (haptic) feedback stimulation (e.g. [0203]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with at least one of the stimulation devices having a tactile (haptic) stimulation feedback which has at least one stimulation channel as taught by Grahn in order to provide the predictable results of providing interaction with the user and activating motor function to the user having incomplete or complete spinal cord injury.
Regarding claim 11, Averkiev in view of Just teaches the claimed invention as discussed above except for at least one of the stimulation devices comprises more than one stimulation channel.
Grahn teaches at least one stimulation device that comprises more than one stimulation channel (e.g. [0059]: waveform generator 110 to stimulate a subset of electrodes). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with at least one stimulation device that comprises more than one stimulation channel as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 12, Averkiev in view of Just teaches the claimed invention as discussed above except for at least one of the stimulation devices comprising at least one invasive stimulation element.
Grahn teaches surgically implanting a stimulation generator and epidural electrodes (e.g. [0059]) and therefore they teach at least one stimulation device comprising at least one invasive stimulation element. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with at least one of the stimulation devices comprising at least one invasive stimulation element as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 13, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one stimulation device is configured to use the registered signals by at least one registering device for configuring parameters (e.g.[0148]: a command 14 is transmitted to the robotic device to impact the trained object 15 to perform the intended movement, the robotic exoskeleton allows for optimal anatomical parameterization). They do not teach configuring stimulation parameters.
Grahn teaches configuring stimulation parameters (e.g. [0059]: The controller 106 is a data processing apparatus that selects parameters for the waveforms generated by each of the waveform generators 110). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with at least one stimulation device being configured to use the registered signals by at least one registering device for configuring stimulation parameters as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 14, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one stimulation device is configured to use the registered signals by at least one registering device for configuring parameters (e.g.[0148]: a command 14 is transmitted to the robotic device to impact the trained object 15 to perform the intended movement, the robotic exoskeleton allows for optimal anatomical parameterization). They do not teach configuring stimulation parameters of at least one stimulation device.
Grahn teaches configuring stimulation parameters (e.g. [0059]: The controller 106 is a data processing apparatus that selects parameters for the waveforms generated by each of the waveform generators 110). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with at least one stimulation device being configured to use the registered signals by at least one registering device for configuring stimulation parameters of at least one stimulation device as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 23, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches at least one parameter of at least one device is being changed based on the stage of a rehabilitation training exercise execution and/or on a stage of visual-motor transformation process determined using the registered signals of the neural activities (e.g. [0155]): It is possible to implement the neurorehabilitation method, in which the task, registration of signals and commands to perform the task are divided into several stages, while each stage of the task can be recorded by a different device, performed by different parts of the trained object, and each stage is displayed on the visual display device 1 independently. Thus, the invention makes it possible to simulate the implementation of complex multi-stage movements, similar to those performed by the patient in real life, and thus to carry out complex rehabilitation of the limb. In this case a more and less intact function are immediately restored in the same exercise).
They do not specifically teach at least one stimulation parameter of at least one stimulation device is being changed. Grahn teaches changing at least one stimulation parameter of at least one stimulation device (e.g. [0063]: Waveform parameters and stimulation programs can be optimized). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just to adjust at least one stimulation parameter of at least one stimulation device based on the stage of a rehabilitation training exercise execution as taught by Grahn in order to provide the predictable results of customizing therapy further to activate motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claims 31-33, Averkiev in view of Just teaches the claimed invention as discussed above except for applying the electrical stimulation by at least two channels below and above the level of the spinal cord injury lesion and wherein the electrical stimulation by at least two channels is applied at a cervical spinal cord level, a thoracic spinal cord level, or/and a lumbar spinal cord level and wherein the electrical stimulation by at least one channel is applied at a spinal cord injury sublesional level.
Grahn teaches applying electrical stimulation by applying the electrical stimulation by at least two channels below and above the level of the spinal cord injury lesion and wherein the electrical stimulation by at least two channels is applied at a cervical spinal cord level, a thoracic spinal cord level, or/and a lumbar spinal cord level and wherein the electrical stimulation by at least one channel is applied at a spinal cord injury sublesional level (e.g. [0061],[0091],[0092],[0132],[0133]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just to include the epidural stimulation system as taught by Grahn in order to provide the predictable results of customizing therapy further to activate motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 34, Averkiev in view of Just teaches the claimed invention as discussed above except for the electrical stimulation by at least two channels is applied to peripheral nerves and to the spinal cord respectively.
Grahn teaches applying electrical stimulation by at least two channels to peripheral nerves and to the spinal cord respectively (e.g. [0018]:The plurality of electrodes can be configured to be disposed at various locations on nerve tissue of a mammal, Each waveform generator can be coupled to a different subset of the plurality of electrodes and can be configured to energize its corresponding subset of the plurality of electrodes, thereby stimulating local nerve tissue proximate to the corresponding subset of the plurality of electrodes and activating a muscle group associated with the local nerve tissue,[0060]: the system 100 is configured to facilitate walking in an individual with a complete or partial SCI and paralyzed legs. Electrodes 112 are positioned on the dura of the spine to target select spinal motor pools associated with enabling desire movements of each leg). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just to include the peripheral and spinal cord stimulation system as taught by Grahn in order to provide the predictable results of customizing therapy further to activate motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 36, Averkiev in view of Just teaches the claimed invention as discussed above except for the electrical stimulation by at least two channels being applied to the spinal cord by electrodes placed in accordance with orientation of the spinal cord neural roots to achieve the optimal level of neural excitation.
Grahn teaches wherein the electrical stimulation by at least two channels is applied to the spinal cord by electrodes placed in accordance with orientation of the spinal cord neural roots to achieve the optimal level of neural excitation (e.g. [0062], [0065]: targeted stimulation of the dorsal root entry zones). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just to include the electrical stimulation by at least two channels being applied to the spinal cord by electrodes placed in accordance with orientation of the spinal cord neural roots to achieve the optimal level of neural excitation as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 37, Averkiev in view of Just teaches the claimed invention as discussed above except for a timing of the electrical stimulation by at least two stimulation channels placed at the multiple spinal cord levels is determined to achieve the optimal level of neural excitation at each level at each moment.
Grahn teaches a timing of the electrical stimulation by at least two stimulation channels placed at the multiple spinal cord levels is determined to achieve the optimal level of neural excitation at each level at each moment (e.g. [0060]: The waveforms applied to each subset of electrodes can be independently optimized, so as to optimize timing and position of probes and waveform parameters for multiple stimulation programs (e.g., waveform) executed concurrently). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with a timing of the electrical stimulation by at least two stimulation channels placed at the multiple spinal cord levels being determined to achieve the optimal level of neural excitation at each level at each moment as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Regarding claim 38, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein the electrical stimulation by at least two stimulation channels placed at multiple spinal cord levels can be delivered simultaneously, or consecutive, or sequentially, or alternating.
Grahn teaches electrical stimulation by at least two stimulation channels placed at multiple spinal cord levels is delivered simultaneously, or consecutive, or sequentially, or alternating (e.g. [0005). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with the electrical stimulation by at least two stimulation channels placed at multiple spinal cord levels being delivered simultaneously, or consecutive, or sequentially, or alternating as taught by Grahn in order to provide the predictable results of activating motor function in one or more limbs in a person having complete or incomplete spinal cord injury.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of JUST al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED) and further in view of Formento et al (U.S. Patent Application Publication Number: US 2020/0056116 A1, hereinafter “Formento”- APPLICANT CITED).
Regarding claim 26, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein the excitability threshold of the sensorimotor system of a patient or its part towards which the stimulation during the exercise is directed is being measured before rehabilitation by sending consecutive stimuli with increasing amplitude and measuring responses of the sensorimotor system after every stimulus to determine that the sensorimotor system reached the excitation threshold.
In a similar field of endeavor, Formento teaches a system for stimulation of the spinal cord for the rehabilitation of motor function in subjects with spinal cord injury (e.g. abstract) and further teaches the excitability threshold of the sensorimotor system of a patient or its part towards which the stimulation during the exercise is directed is being measured before rehabilitation by sending consecutive stimuli with increasing amplitude and measuring responses of the sensorimotor system after every stimulus to determine that the sensorimotor system reached the excitation threshold( e.g. [0093], [0102],[0217]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just to include measuring an excitability threshold of the sensorimotor system of a patient or its part towards which the stimulation during the exercise is directed before rehabilitation by sending consecutive stimuli with increasing amplitude and measuring responses of the sensorimotor system after every stimulus to determine that the sensorimotor system reached the excitation threshold as taught by Formento in order to provide the predictable results of increasing spinal excitability while minimizing destructive interference with sensory information and thus improving recovery of motor function in the subject.
Regarding claim 27, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein before the start of the rehabilitation, a preliminary stimulation by at least one channel of at least one stimulation device is delivered with a stimulation amplitude above the excitation threshold of the sensorimotor system or its part towards which stimulation is primarily directed, in order to excitate the later before exercising.
Formento teaches before the start of the rehabilitation, a preliminary stimulation by at least one channel of at least one stimulation device is delivered with a stimulation amplitude above the excitation threshold of the sensorimotor system or its part towards which stimulation is primarily directed, in order to excitate the later before exercising(e.g. [0037]: using suprathreshold amplitudes that normally induce a motor response even when the subject is in a resting condition, [0064]: “Motor threshold amplitude” means the minimum amplitude necessary to induce a motor response with a single pulse of stimulation of the spinal cord.[0106]: Amplitude is comprised between 0.1 motor threshold amplitude and 1.5 motor threshold amplitude.). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with before the start of the rehabilitation, delivering a preliminary stimulation by at least one channel of at least one stimulation device with a stimulation amplitude above the excitation threshold of the sensorimotor system or its part towards which stimulation is primarily directed, in order to excitate the later before exercising as taught by Formento in order to provide the predictable results of increasing spinal excitability while minimizing destructive interference with sensory information and thus improving recovery of motor function in the subject.
Regarding claim 28, Averkiev in view of Just teaches the claimed invention as discussed above and Averkiev teaches stimulation by at least one channel of at least one stimulation device is synchronized with action of at least one impact device ( e.g. [0009]: electrostimulator 5 makes it possible to implement electrical stimulation in the neurorehabilitation system, which consists of the simultaneous movement of the trained object by the robotic device 4 with a specific electrical effect through the skin on certain muscle and nerve fibers in order to enhance biofeedback and stimulate the muscles own activity and the formation of patterns of neuronal activity corresponding to the implementation of desired movements.).
They do not specially teach that when the impacting action is ongoing, the stimulation amplitude is set above the excitation threshold of the sensorimotor system or its part towards which stimulation is directed, and when there is no ongoing impacting action, the stimulation amplitude is set below the excitation threshold.
Formento teaches when impacting action is ongoing, the stimulation amplitude is set above the excitation threshold of the sensorimotor system or its part towards which stimulation is directed, and when there is no ongoing impacting action, the stimulation amplitude is set below the excitation threshold (e.g. [0037],[0064][0065], [0108]-[0109]: system provides excitation to spinal circuits without eliciting any involuntary motor contraction which is achieved with stimulation below motor threshold amplitude when motor contraction is not intended and above the motor threshold amplitude when motor contraction is intended). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Everkiev in view of Just with the teachings of Formento in order to provide the predictable results of increasing spinal excitability while minimizing destructive interference with sensory information and thus improving recovery of motor function in the subject.
Claim 29 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of JUST al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED) and further in view of Fang et al (U.S. Patent Application Publication Number: US 2009/0204173 A1, hereinafter “Fang”- APPLICANT CITED).
Regarding claim 29, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein the stimulation is being consecutively delivered by at least two channels of at least one stimulation device with changing amplitudes, so that at the same time at some channels the amplitude is below and at some channels above the excitation threshold of the sensory system or its part towards which stimulation is primarily directed, thereby forming a wave propagating down the neural pathways.
Fang teaches multifrequency neural treatment (e.,5. abstract) and teaches stimulation being consecutively delivered by at least two channels of at least one stimulation device with changing amplitudes, so that at the same time at some channels the amplitude is below and at some channels above the excitation threshold of the sensory system or its part towards which stimulation is primarily directed, thereby forming a wave propagating down the neural pathways (e.g. [0051],Fig. 4 [0067]-[0070], Fig. 14, [0107]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with stimulation being consecutively delivered by at least two channels of the at least one stimulation device with changing amplitudes, so that at the same time at some channels the amplitude is below and at some channels above the excitation threshold of the sensory system or its part towards which stimulation is primarily directed, thereby forming a wave propagating down the neural pathways as taught by Fang in order to provide the predictable results of providing a more effective therapeutic protocol.
Claims 35 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of JUST al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED) and further in view of Annoni et al (U.S. Patent Application Publication Number: US 2018/0110464 A1, hereinafter “Annoni”- APPLICANT CITED).
Regarding claim 35, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein the electrical stimulation by at least two channels is applied to the spinal cord and to the brain cortex respectively.
In a similar field of endeavor, Annoni teaches providing electrical stimulation by at least two channels is applied to the spinal cord and to the brain cortex respectively (e.g. [0052]: Pain relief device 206 can deliver one or more pain relief therapies, such as any one or any combination of spinal cord stimulation (SCS), dorsal root ganglia (DRG) stimulation, deep brain stimulation (DBS), motor cortex stimulation (MCS), transcranial direct current stimulation (tDCS),). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with a combination stimulation to the brain and spinal cord as taught by Annoni in order to provide the predictable results of providing a more effective stimulation to treat pain as well as motor therapy.
Regarding claim 39, Averkiev in view of Just teaches the claimed invention as discussed above except for the electrical stimulation by at least two channels is delivered in a form of alternating current stimulation by at least one channel, and direct current stimulation by at least one channel.
In a similar field of endeavor, Annoni teaches providing electrical stimulation by at least two channels being delivered in a form of alternating current stimulation by at least one channel, and direct current stimulation by at least one channel (e.g. [0052] : Pain relief device 206 can deliver one or more pain relief therapies, such as any one or any combination of spinal cord stimulation (SCS), dorsal root ganglia (DRG) stimulation, deep brain stimulation (DBS), motor cortex stimulation (MCS), transcranial direct current stimulation (tDCS), transcutaneous spinal direct current stimulation (tsDCS), transcranial alternating current stimulation (tACS)). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Averkiev in view of Just with a combination stimulation to the brain and spinal cord as taught by Annoni in order to provide the predictable results of providing a more effective stimulation to treat pain as well as motor therapy.
Claim 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Averkiev et al (U.S. Patent Application Publication Number: US 2022/0187913 A1, hereinafter “Averkiev”- APPLICANT CITED) in view of JUST al ("Feedforward Model Based Arm Weight Compensation with the Rehabilitation Robot ARMin" 2017 International Conference of Rehabilitation Robotics (ICORR), July 17-20, 2017, pages 72-77, hereinafter “Just”- APPLICANT CITED) and further in view of De Groote, Sander, et al. ("Functional magnetic resonance imaging: cerebral function alterations in subthreshold and suprathreshold spinal cord stimulation" Journal of Pain Research, 2018, 2517-2526 , herein after “De Groote” - APPLICANT CITED).
Regarding claim 40, Averkiev in view of Just teaches the claimed invention as discussed above except for wherein the electrical stimulation by at least one channel is delivered with a subthreshold current amplitude for a prolonged period of time, prior to or after the rehabilitation in accordance with claim 18 and the electrical stimulation by at least one channel is increased to a suprathreshold current amplitude level after a period of stimulation at the subthreshold current amplitude level.
In a similar field of endeavor, De Groote teaches spinal cord stimulation wherein the electrical stimulation by at least one channel is delivered with a subthreshold current amplitude for a prolonged period of time, prior to or after the rehabilitation and the electrical stimulation by at least one channel is increased to a suprathreshold current amplitude level after a period of stimulation at the subthreshold current amplitude level. (e.g. Page 2519 col.1 para 4 – col. 2 para 2). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of wherein the electrical stimulation by at least one channel is delivered with a subthreshold current amplitude for a prolonged period of time, prior to or after the rehabilitation in accordance with claim 18 and the electrical stimulation by at least one channel is increased to a suprathreshold current amplitude level after a period of stimulation at the subthreshold current amplitude level as taught by De Groote in order to provide the predictable results of determining specific supraspinal effects between supra and subthreshold SCS in relation to different frequencies by identifying the functional cerebral regions involved in short-term sub- and suprathreshold SCS in patients.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Firlik et al (U.S. Patent Application Publication Number: US 2007/0179534 A1, hereinafter “Firlik”) teaches a patient interactive neural stimulation system and method providing a display device for task execution progress, registering devices, stimulation devices and impacting devices to provide rehabilitation to a patient (e.g. Figs. 1A,2,3,7, 8, 10A).
Contreras-Vidal et al (U.S. Patent Application Publication Number: US 2007/0179534 A1, hereinafter “Contreras- Vidal”) teaches Brain-Machine Interface (BMI) systems or movement-assist systems may be utilized to aid users with paraplegia or tetraplegia in ambulation or other movement or in rehabilitation of motor function after brain injury or neurological disease, such as stroke, Parkinson's disease or cerebral palsy.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
